US5637322A - Method for producing composition for solid medicine - Google Patents

Method for producing composition for solid medicine Download PDF

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Publication number
US5637322A
US5637322A US08/433,351 US43335195A US5637322A US 5637322 A US5637322 A US 5637322A US 43335195 A US43335195 A US 43335195A US 5637322 A US5637322 A US 5637322A
Authority
US
United States
Prior art keywords
cellulose
solvent
potassium channel
channel activator
pharmaceutical composition
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Fee Related
Application number
US08/433,351
Other languages
English (en)
Inventor
Kiyoshi Tamura
Ken-ichi Sugimori
Kenji Ogawa
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Japan Tobacco Inc
Welfide Corp
Original Assignee
Japan Tobacco Inc
Welfide Corp
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Japan Tobacco Inc, Welfide Corp filed Critical Japan Tobacco Inc
Assigned to YOSHITOMI PHARMACEUTICAL INDUSTRIES,LTD., JAPAN TOBACCO INC. reassignment YOSHITOMI PHARMACEUTICAL INDUSTRIES,LTD. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: OGAWA, KENJI, TAMURA, KIYOSHI, SUGIMORI, KEN-ICHI
Application granted granted Critical
Publication of US5637322A publication Critical patent/US5637322A/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/35—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/4406—Non condensed pyridines; Hydrogenated derivatives thereof only substituted in position 3, e.g. zimeldine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/35—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom
    • A61K31/352—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom condensed with carbocyclic rings, e.g. methantheline 
    • A61K31/353—3,4-Dihydrobenzopyrans, e.g. chroman, catechin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
    • A61K31/4025—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil not condensed and containing further heterocyclic rings, e.g. cromakalim
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/4409—Non condensed pyridines; Hydrogenated derivatives thereof only substituted in position 4, e.g. isoniazid, iproniazid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/146—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic macromolecular compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose

Definitions

  • pulverizing crystals in a certain range with good reproducibility is not easy, and control of elution rate relying on pulverizing is associated with difficulty.
  • the method comprising coating of the drug is also defective in that the production steps become complicated and the cost tends to be higher.
  • excipients for solid preparations such as powder, granule and tablet include, for example, organic excipients such as saccharides (e.g. lactose, glucose, mannit and sorbit), starches (e.g. corn starch and dextrin), celluloses [e.g. crystalline cellulose (MCC), low substituted hydroxypropyl cellulose (L-HPC) and internally crosslinked sodium carboxymethyl cellulose (CMC-Na)], gum arabic, dextran and pullulan; and inorganic excipients such as light anhydrous silicate, synthetic aluminum silicate, calcium phosphate, sodium carbonate and calcium sulfate.
  • organic excipients such as saccharides (e.g. lactose, glucose, mannit and sorbit), starches (e.g. corn starch and dextrin), celluloses [e.g. crystalline cellulose (MCC), low substituted hydroxypropyl cellulose (L-HPC) and internally crosslinked sodium
  • solvents may be used alone or in combination, or optionally in the form of a mixed solvent with water.
  • a preparation exhibiting an elution rate of 30% in 10 minutes is obtained by adding a cellulose polymer to a potassium channel activator in a weight ratio of 1:5 (potassium channel activator being 1), which is a necessary and sufficient amount to achieve the predetermined elution rate, as is evident from Example 1 to follow. While the preferable content ratio (weight ratio) is 1:5-15, this ratio is not limitative and may be altered according to the object.
  • Mixing can be done, for example, using a known stirrer-mixer such as high speed mixer and the like.

Landscapes

  • Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
US08/433,351 1992-11-06 1993-11-05 Method for producing composition for solid medicine Expired - Fee Related US5637322A (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
JP32142792 1992-11-06
JP4-321427 1992-11-06
PCT/JP1993/001603 WO1994010998A1 (en) 1992-11-06 1993-11-05 Method of manufacturing composition for solid medicine

Publications (1)

Publication Number Publication Date
US5637322A true US5637322A (en) 1997-06-10

Family

ID=18132432

Family Applications (1)

Application Number Title Priority Date Filing Date
US08/433,351 Expired - Fee Related US5637322A (en) 1992-11-06 1993-11-05 Method for producing composition for solid medicine

Country Status (5)

Country Link
US (1) US5637322A (ko)
EP (1) EP0667153A4 (ko)
KR (1) KR950703947A (ko)
CA (1) CA2148220A1 (ko)
WO (1) WO1994010998A1 (ko)

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4656027A (en) * 1981-06-18 1987-04-07 Astra Lakemedel Aktiebolag Pharmaceutical mixture
US4720387A (en) * 1983-06-22 1988-01-19 Shionogi & Co., Ltd. Sustained-release preparation of pinacidil
US4822808A (en) * 1986-01-17 1989-04-18 Chugai Seiyaku Kabushiki Kaisha Method for production of stable nicorandil preparation
US5011837A (en) * 1988-08-09 1991-04-30 E. R. Squibb & Sons, Inc. Aryl cyanoguanidines: potassium channel activators and method of making same
US5250547A (en) * 1991-08-29 1993-10-05 Syntex (U.S.A.) Inc. Benzopyran derivatives

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS5547615A (en) * 1978-09-29 1980-04-04 Taiyo Yakuhin Kogyo Kk Stable solid drug of nifedipine
JP2680602B2 (ja) * 1987-04-24 1997-11-19 第一製薬株式会社 徐放性錠剤
JPH01319416A (ja) * 1988-06-21 1989-12-25 Dai Ichi Kogyo Seiyaku Co Ltd 放出制御可能な錠剤結合剤
CA2055376A1 (en) * 1990-12-05 1992-06-06 Gary J. Grover Method of treating shock using a potassium channel activator

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4656027A (en) * 1981-06-18 1987-04-07 Astra Lakemedel Aktiebolag Pharmaceutical mixture
US4720387A (en) * 1983-06-22 1988-01-19 Shionogi & Co., Ltd. Sustained-release preparation of pinacidil
US4822808A (en) * 1986-01-17 1989-04-18 Chugai Seiyaku Kabushiki Kaisha Method for production of stable nicorandil preparation
US5011837A (en) * 1988-08-09 1991-04-30 E. R. Squibb & Sons, Inc. Aryl cyanoguanidines: potassium channel activators and method of making same
US5250547A (en) * 1991-08-29 1993-10-05 Syntex (U.S.A.) Inc. Benzopyran derivatives
US5447943A (en) * 1991-08-29 1995-09-05 Syntex (U.S.A.) Inc. Novel benzopyran derivatives

Also Published As

Publication number Publication date
EP0667153A4 (en) 1996-03-13
EP0667153A1 (en) 1995-08-16
WO1994010998A1 (en) 1994-05-26
CA2148220A1 (en) 1994-05-26
KR950703947A (ko) 1995-11-17

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AS Assignment

Owner name: JAPAN TOBACCO INC., JAPAN

Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:TAMURA, KIYOSHI;SUGIMORI, KEN-ICHI;OGAWA, KENJI;REEL/FRAME:007663/0696;SIGNING DATES FROM 19950414 TO 19950509

Owner name: YOSHITOMI PHARMACEUTICAL INDUSTRIES,LTD., JAPAN

Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:TAMURA, KIYOSHI;SUGIMORI, KEN-ICHI;OGAWA, KENJI;REEL/FRAME:007663/0696;SIGNING DATES FROM 19950414 TO 19950509

REMI Maintenance fee reminder mailed
LAPS Lapse for failure to pay maintenance fees
FP Lapsed due to failure to pay maintenance fee

Effective date: 20010610

STCH Information on status: patent discontinuation

Free format text: PATENT EXPIRED DUE TO NONPAYMENT OF MAINTENANCE FEES UNDER 37 CFR 1.362